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| Sponsor: | University of Pennsylvania |
|---|---|
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00957827 |
Purpose
Facial lacerations are a commonly encountered problem in the emergency department. Despite this, few original articles have been written concerning the management of lacerations of the lip which communicate with the oral cavity. Specifically, no study has been able to definitively show whether the use of antibiotics for these wounds decreases the infection rate. These cutaneous wounds are a unique type of laceration because they are continuously contaminated with oropharyngeal flora. Contaminated wounds result in larger, less cosmetic scars. Scars which involve the face have been shown to have a negative psychological impact. In this study, the investigators aim to determine whether the use of antibiotics decrease the rate of infection in lacerations of the lip which communicate with the oral cavity. Patients will be randomized to one of three currently practiced therapies. Patients will receive either cephalexin, chlorhexidine or no treatment following the repair of their through-and-through lip lacerations to determine whether antibiotics decrease the infection rate in these wounds.
| Condition | Intervention |
|---|---|
|
Through-and-through Lip Lacerations |
Drug: keflex Drug: peridex Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Prophylactic Use of Antibiotics for Through and Through Lacerations of the Lip |
| Estimated Enrollment: | 378 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
keflex: Experimental
keflex 500mg twice a day for five days
|
Drug: keflex
keflex 500 mg BID 5 days
|
|
peridex: Experimental
0.12% peridex twice a day for five days
|
Drug: peridex
0.12% 30ml BID for five days
|
| placebo: Placebo Comparator |
Drug: placebo
placebo BID for five days
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joli Chou, M.D., D.M.D. | 215 662-3580 | joli.chou@uphs.upenn.edu |
| Contact: Eric Granquist, M.D., D.M.D. | 215 880-7568 | eric.granquist@uphs.upenn.edu |
| United States, Pennsylvania | |
| Hopital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Joli Chou, M.D., D.M.D. 215-662-3580 eric.granquist@uphs.upenn.edu | |
| Principal Investigator: | Carrie Sims, M.D. | University of Pennsylvania |
More Information
| Responsible Party: | University of Pennsylvania Health System ( Carrie Sims ) |
| Study ID Numbers: | 809859 |
| Study First Received: | August 11, 2009 |
| Last Updated: | December 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00957827 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Lacerations Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses |
Wounds and Injuries Disorders of Environmental Origin Pharmacologic Actions |